Safety pen needle assembly

ABSTRACT

In one aspect, a safety pen needle assembly is provided which includes a hub, a needle fixed to the hub, and a shield formed to at least partially telescope over the hub. Thread elements permit relative rotation between the hub and the shield. Initially, the elements are in threaded engagement with the shield being positioned relative to the hub with a distal end of the shield sidewall being located distally of a distal end of the needle. Also, in the initial state, the shield and the hub are configured with a rotation-resistance arrangement which inhibits relative rotation between the hub and the shield. The rotation-resistance arrangement is surmountable to allow relative rotation between the hub and the shield with an at least threshold amount of torque being applied, the threshold amount of torque being greater than required to mount the pen needle assembly onto an injector body.

FIELD OF THE INVENTION

This invention relates to safety pen needle assemblies.

BACKGROUND OF THE INVENTION

Safety pen needle assemblies are well known in the art for use withmedical injectors, particularly pen injectors. Shielding of a usedneedle post-injection is provided by such devices. Variousconfigurations for shielding are available, including a displaceableshield relative to the needle hub. U.S. Pat. No. 5,964,731 to Kovelmandiscloses a shield threaded onto a needle hub. With this configuration,however, the shield must be in its most extreme lowest position, whereinthe needle is maximally exposed, for mounting onto a medical injector.As such, a user may inadvertently suffer a needle stick during mounting.Transmission of biological material or disease is not a concern with theneedle being in a clean state; however, with a practitioner suffering aneedle stick, the pen needle assembly must be disposed of since theneedle can not be used subsequently on a patient.

SUMMARY OF THE INVENTION

In one aspect, a safety pen needle assembly is provided which includes ahub, a needle fixed to a transverse wall of the hub, and a shield formedto at least partially telescope over the hub. An outer ablumenal surfaceof the hub and an inner lumenal surface of the shield are formed withcooperating thread elements to permit relative rotation between the huband the shield. In an initial state, the cooperating thread elements arein threaded engagement with the shield being positioned relative to thehub with a distal end of the shield sidewall being located distally of adistal end of the needle. Also, in the initial state, the shield and thehub are configured with a rotation-resistance arrangement which inhibitsrelative rotation between the hub and the shield. Therotation-resistance arrangement is surmountable to allow relativerotation between the hub and the shield with an at least thresholdamount of torque being applied, the threshold amount of torque beinggreater than required to mount the pen needle assembly onto an injectorbody. Advantageously, with the subject invention, a safety pen needleassembly can be provided having a shield threaded onto a hub with theassembly being mountable with the needle being in a shielded state. Thisminimizes the possibility of needle stick during mounting of the safetypen needle assembly.

Additionally, a safety pen needle assembly is provided having. a hubwith an open proximal end; a needle fixed to the hub, the needle havinga distal end, formed for insertion into a patient, and a proximal end;and, a shield moveably mounted to the hub so as to be moveable relativeto the hub to selectively cover the distal end of the needle, the shieldhaving an open distal end. An interface is defined between the shieldand the hub, which is sufficiently sealed by portions of one or both ofthe hub and the shield so as to define a sterility barrier whichprevents ingressive contaminants through the interface. Also, at leastone removable sterility barrier is mounted across the open proximal endof the hub and the open distal end of the shield. Advantageously, withthe subject invention, a safety pen needle assembly can be providedwhich does not require any additional packaging for storage ortransportation. With a sterility barrier being defined between theshield and the hub, and the removable sterility barrier being providedto seal open portions of the shield and hub, a fully sealed pen needleassembly is provided.

As used herein, the term “distal”, and derivatives thereof, refers to adirection towards a patient during use. The term “proximal”, andderivatives thereof, refers to a direction away from a patient duringuse.

These and other features of the invention will be better understoodthrough a study of the following detailed description and accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a safety pen needle assembly formed inaccordance with the subject invention in an initial state;

FIG. 2 is a schematic of a safety pen needle assembly of FIG. 1 in aninitial state;

FIG. 3 is a partial cross-sectional view of a hub useable with thesubject invention;

FIGS. 4-7 show different rotation-resistance arrangements useable withthe subject invention;

FIG. 8 is a perspective view of a safety pen needle assembly in aready-to-use state mounted on an injector body;

FIG. 9 is a schematic of a safety pen needle assembly of FIG. 8 in aready-to-use state;

FIG. 10 is a schematic of a safety pen needle assembly formed inaccordance with the subject invention in a post-use state;

FIG. 11 is a schematic of a safety pen needle assembly formed inaccordance with the subject invention using a different shieldconfiguration;

FIG. 12 is a schematic of a safety pen needle assembly formed inaccordance with the subject invention utilizing a secondary shield for aproximal end of a needle;

FIG. 13 is a schematic of a safety pen needle assembly of FIG. 12 inpost-use state;

FIG. 14 is a cross-sectional view of a safety pen needle assembly ofFIG. 12 in an initial state with the proximal end of the needle exposed;

FIG. 15 is a cross-sectional view of a safety pen needle assembly ofFIG. 12 in a post-use state;

FIG. 16 is a schematic of a safety pen needle assembly formed inaccordance with the subject invention in a packaged state;

FIGS. 17-20 show a cap or plug useable with the subject invention;

FIGS. 21-22 show a snap-on cap useable with the subject invention; and,

FIGS. 23-24 show an end cap useable with the subject invention.

DETAILED DESCRIPTION OF THE INVENTION

With reference to the Figures, a safety pen needle assembly 10 is shownwhich generally includes a hub 12, a needle 14, and a shield 16. Thesafety pen needle assembly 10 is formed for mounting onto variousinjector bodies I and is particularly well-suited for use with peninjectors.

The hub 12 includes a tubular side wall 18 which defines a lumen 20,with an inner lumenal surface 22 and an outer ablumenal surface 24, anda proximal opening 23. A transverse wall 26 extends transversely fromthe side wall 18 to overlap at least a portion of the lumen 20.Preferably, the transverse wall 26 overlaps completely the lumen 20. Thelumenal surface 22 is formed with features 28 for mounting the hub 12onto the injector body I. Preferably, the mounting features 28 is athread element formed for threaded engagement with a cooperating threadon the injector body I. As will be appreciated by those skilled in theart, the features 28 may include additional or different features, suchas mechanical locking elements (bayonet-type locking elements, snapablelocking elements) and/or surface configurations, such as for frictionfit, e.g., a Luer configuration.

The needle 14 is fixed to the transverse wall 26 using any knowntechnique, including adhesive or insert molding. As best shown in FIG.3, the needle 14 includes a distal end 30, formed for insertion into apatient, and a proximal end 32. A lumen 34 extends between, and is incommunication with, the distal and proximal ends 30, 32. The needle 14is fixed such that the distal end 30 is located distally of thetransverse wall 26 and that the proximal end 32 is located proximally ofthe transverse wall 26.

The shield 16 is generally tubular and includes a shield side wall 36which extends between proximal and distal ends 38, 40, respectively. Theshield side wall 36 is formed to at least partially telescope over thehub 12, as shown in FIG. 2. The shield side wall 36 defines a shieldlumen 42 with an inner shield lumenal surface 44 and an outer shieldablumenal surface 46. The proximal end 38 of the shield side wall 36defines proximal opening 48, in which the hub 12 is nestingly received,and the distal end 40 defines distal opening 50, formed large enough topermit passage therethrough of the needle 14 as described below.

The ablumenal surface 24 of the hub 12 and the shield lumenal surface 44are formed with cooperating thread elements 52, 54 which permit relativerotation between the hub 12 and the shield 16.

In an initial state, as shown in FIGS. 1 and 2, the shield 16 ispositioned relative to the hub 12 with the distal end 40 of the shieldside wall 36 being located distally of the distal end 30 of the needle14. As such, the needle 14 is covered by the shield 16 in the initialstate.

The hub 12 and the shield 16 are configured with a rotation-resistancearrangement 56 which inhibits relative rotation between the hub 12 andthe shield 16, particularly from the initial state. Therotation-resistance arrangement 56 is surmountable to allow relativerotation between the hub 12 and the shield 16 with an at least thresholdamount of torque being applied therebetween. The threshold amount oftorque is to be greater than the amount of torque required to mount thesafety pen needle assembly 10 onto the injector body I.

The rotation-resistance arrangement 56, as will be appreciated by thoseskilled in the art, can be provided in various arrangements. Forexample, as shown in FIG. 4, the rotation-resistance arrangement 56 maybe defined by one or more points of securement 58 formed by adhesion,welding and/or fusion. The points of securement 58 may be continuous ordiscontinuous about the hub 12. The points of securement 58 may beruptured, or otherwise caused to fail, with application of the thresholdamount of torque between the hub 12 and the shield 16. The one or morepoints of securement 58 may be also defined by portions integrallyformed with the hub 12 and/or the shield 16, such as by injectionmolding (FIG. 5). The hub 12 and the shield 16 may be integrally formedtogether with the one or more points of securement 58 being configuredto fail upon the threshold amount of torque being applied between thehub 12 and the shield 16, such as by providing the one or more points ofsecurement 58 as thinned or weakened sections and/or providingperforations 60 (shown in dashed lines), or other discontinuities, inbetween the points of securement 58.

The rotation-resistance arrangement 56 may be also achieved by africtional or mechanical configuration, whereby an increased amount oftorque is required to overcome a higher friction area or mechanicalcombination. For example, select portions 62 (FIG. 6) of the cooperatingthread elements 52, 54 may be formed to have higher frictionalengagement, such as by greater surface interaction, deeper threadinterengagement, and so forth where the higher frictional engagement maybe overcome by application of the threshold amount of torque between thehub 12 and the shield 16. For example, the select portions 62 may definenarrower threads than surrounding portions of the cooperating threadelements 52, 54. In this manner, the portions 62 are in tighterengagement than surrounding portions of the cooperating thread elements52, 54. With rotational displacement, upon sufficient application oftorque, the portions 62 disengage apart and rotate to engage theadjacent wider threads, thereby easing the initial tightness of theengagement between the portions 62.

Cooperating locking elements 64 (FIG. 7) may be also provided to act asa mechanical interconnection, such as, for example, snap detents. Withsufficient application of torque, the cooperating locking elements 64may be disengaged, such as, for example, snap release of the snapdetents. As will be appreciated by those skilled in the art, the variousconfigurations described herein for the rotation-resistance arrangement56 may be used singularly or in various combinations.

During use, with reference to FIG. 8, the safety pen needle assembly 10is mounted onto the injector body I with handling of the shield 16.Rotational force is applied to the safety pen needle assembly 10 so asto cause the features 28 to engage cooperating features 66 on theinjector body I. With the torque threshold required to surmount therotation-resistance arrangement 56 being greater than the torquerequired to mount the safety pen needle assembly 10 onto the injectorbody I, the torque applied to the shield 16 is directly transmitted tothe hub 12 with the shield 16 and the hub 12 rotating in concerttogether. With the hub 12 being fully mounted onto the injector body I,and continued application of torque to the shield 16, therotation-resistance arrangement 56 may be overcome with relativerotation between the shield 16 and the hub 12 being achieved. Thecooperating thread elements 52, 54 are configured to permit proximalmovement of the shield 16 relative to the hub 12 during mounting so asto permit exposure of the distal end 30 of the needle 14. Preferably,the features 28 in the form of a thread have the same angularorientation as the cooperating thread elements 52, 54 to permit rotationby a user in a single direction to both achieve mounting of the safetypen needle assembly 10 onto the injector body I and proximaldisplacement of the shield 16 relative to the hub 12.

With reference to FIGS. 8 and 9, with proximal displacement of theshield 16, the needle 14, particularly the distal end 30, becomesexposed through the distal opening 50 and ready for use. It is preferredthat the shield 16 be rotated until it bottoms out. To control theextent of displacement of the shield 16 relative to the hub 12, it ispreferred that a stop be provided. With reference to FIGS. 8 and 9, itis preferred that a shoulder 68 be defined in the shield side wall 36which is formed to interferingly engage against the hub 12 uponsufficient proximal displacement of the shield 16 relative to the hub12. As shown particularly in FIGS. 8 and 9, the shoulder 68 may define atransition in the shield side wall 36 between a larger diameter proximalsection 70 and a smaller diameter distal section 72. Alternatively, asshown in FIG. 11, the proximal and distal sections 70, 72 may be formedwith generally the same diameter, with the shoulder 68 protrudinginwardly from the shield side wall 36.

After use, the shield 16 is caused to rotate in a reverse direction soas to displace the shield 16 distally relative to the hub 12 into ashielded state, as shown in FIG. 10. It is preferred that a lockingarrangement 74 be provided which locks the shield 16 relative to the hub12 in the shielding position. The locking arrangement 74 may becooperating snap or ramped elements which permit one-way rotationtherepast, with resistance against reverse rotation. As will beappreciated by those skilled in the art, various configurations may beutilized.

To permit both displacement from an initial shielded state, as shown inFIGS. 1 and 2, and to achieve a locked shielded state, as shown in FIG.10, it is preferred that the locking arrangement 74 be configured to beengaged with the shield 16, relative to the hub 12, being locateddistally of the position of the shield 16 in the initial state. Moreparticularly, it is preferred that the locking arrangement 74 be locateddistally of the rotation-resistance arrangement 56. Thus, withdisplacement of the shield 16 from the use state to the post-use state,the rotation-resistance arrangement 56 may be bypassed. With sufficientdistal displacement of the shield 16 relative to the hub 12, the lockingarrangement 74 is caused to engage and lock the shield 16 in theshielding state relative to the hub 12.

With reference to FIGS. 12-15, it is additionally possible to providethe safety pen needle assembly 10 with a secondary shield 76 configuredfor shielding the proximal end 32 of the needle 14. The secondary shield76 is at least partially disposed in the lumen 34 of the hub 12. Thesecondary shield 76 includes a secondary shield side wall 78 whichextends between proximal and distal ends 80, 82, respectively. Thesecondary shield side wall 78 defines a secondary shield lumen 84 withan inner secondary shield lumenal surface 86 and an outer secondaryshield ablumenal surface 88. The proximal end 80 of the secondary shieldside wall 78 defines proximal opening 90, formed large enough to permitpassage therethrough of the needle 14, as described below.

The lumenal surface 22 of the hub 12 and the secondary shield ablumenalsurface 88 are formed with secondary cooperating thread elements 92, 94which permit relative rotation between the hub 12 and the secondaryshield 76.

To permit mounting of the safety pen needle assembly 10 onto theinjector body I with use of the secondary shield 76, the features 28 formounting onto the injector body I are formed on the secondary shieldlumenal surface 86, as opposed to the lumenal surface 22 of the hub 12.

In an initial state, the secondary shield 76 is preferably positionedrelative to the hub 12 with the proximal end 80 of the secondary shieldside wall 78 being located proximally of the proximal end 32 of theneedle 14. As such, the proximal end 32 of the needle 14 is covered bythe secondary shield 76 in the initial state. As shown in FIG. 14, inthe initial state, it is preferred that the secondary shield 76 belocated in a distalmost position relative to the hub 12. In this manner,the secondary shield 76 is bottomed out relative to the hub 12 and notcapable of further distal displacement relative to the hub 12.Alternatively, as shown in FIG. 14, the secondary shield 76 may beformed with the proximal end 80 being located distally of the proximalend 32 of the needle 14 so as to not cover the proximal end 32 of theneedle 14 and permit unobstructed visual access thereof.

It is also preferred that the secondary cooperating thread elements 92,94 have the same angular orientation as the features 28 such that thesecondary shield 76 is not displaced proximally relative to the hub 12during mounting onto the injector body I.

After use, the safety pen needle assembly 10 is caused to rotate in areverse direction for dismounting from the injector body I. This resultsin proximal displacement of the secondary shield 76 relative to the hub12, as shown in FIG. 15. A secondary locking arrangement 96, configuredin similar fashion to the locking arrangement 74, may be provided tolock the secondary shield 76 in a shielding position relative to the hub12. In particular, in the shielding position, the proximal end 80 of thesecondary shield side wall 78 would be located proximally of theproximal end 32 of the needle 14. Alternatively, the secondary lockingarrangement 96 need not be utilized. The secondary cooperating threadelements 92, 94 may be configured to allow for maximum extent ofproximal displacement of the secondary shield 76 relative to the hub 12coinciding with the secondary shield 76 shielding the proximal end 32 ofthe needle 14 after use.

During dismount, initial torque applied to the safety pen needleassembly 10 results in the proximal extension of the secondary shield 76relative to the hub 12 to the shielding state. Subsequent application oftorque results in the shield 16 being displaced distally relative to thehub 12 to the shielding position covering the distal end 30 of theneedle 14 in the same manner as described above. As shown in FIG. 15,further application of torque results in the dismounting of the safetypen needle assembly 10 in a fully shielded state from the injector bodyI with both the distal and proximal ends 30, 32 of the needle 14 beingshielded.

With reference to FIGS. 17-20, the safety pen needle assembly 10 may beprovided with a cap or plug for sealing the distal opening 50 in theshield 16 and/or the proximal opening 23 in the hub 12. As will beappreciated by those skilled in the art, various cap or plugconfigurations may be utilized. With reference to FIGS. 17-19, a cap 98is shown for sealing the distal opening 50 in the shield 16. The cap 98includes a base 100 from which extends a rim 102 located about a stem104. The rim 102 and/or the stem 104 are formed to frictionally engagethe shield 16 so as to provide retentive force for the cap 98 to bemaintained on the shield 16. The cap 98 may be formed of any resilientmaterial, such as elastomeric or thermoplastic material, which wouldsufficiently tightly engage the shield 16 so as to define a seal ofsufficient integrity to prevent the ingress of contaminants into theshield 16, particularly through the distal opening 50.

The stem 104 is formed generally cylindrical so as to encompass, withoutcontacting, the needle 14. The stem 104 terminates at a stop edge 106.The length of the stem 104 from the base 100 to the stop edge 106 isselected such that the stop edge 106 is caused to engage the hub 12 withsufficient proximal displacement of the shield 16 relative to the hub12. It is preferred that the full proximal displacement of the shield 16relative to the hub 12 results in at least partial disengagement of thecap 98 from the shield 16. In this manner, removal of the cap 98 fromthe shield 16 is facilitated. By way of non-limiting example, and withreference to FIGS. 18-19, with the rim 102 being in frictionalengagement with the shield 16, the rim 102 and the stem 104 may beconfigured such that full proximal displacement of the shield 16relative to the hub 12 causes full disengagement of the shield 16 fromthe rim 102 (FIG. 19). As will be appreciated by those skilled in theart, full disengagement is not required in that partial disengagementreduces frictional interengagement and still facilitates separation ofthe cap 98 from the shield 16. This also applies where the stem 104 isin friction engagement with the shield 16 since frictionalinterengagement between the two may be reduced by proximal displacementof the shield 16 relative to the hub 12.

With reference to FIG. 20, it is noted that the cap 98 may be providedin the form of a plug 108 where the base 100 and the stem 104 areprovided, but no rim 102. The plug 108 may be configured to perform inthe same manner as the cap 98.

With reference to FIGS. 21-22, a snap-on cap 110 may be provided forsealing the proximal opening 23 and/or the distal opening 50. Thesnap-on cap 110 includes a base 112 from which protrudes a skirt 114.The snap-on cap 110 may be secured to the shield 16 or the hub 12 byfrictional engagement with the skirt 114. To enhance the retentiveforce, detents 116 may be provided on the shield 16 or the hub 12 ontowhich the snap-on cap 110 engages. Further, one or more cooperatingdetents 118 may be provided on the skirt 114 to further enhance theholding force. Two of the snap-on caps 110 may be simultaneouslyprovided with one for sealing the proximal opening 23 and the second forsealing the distal opening 50. It is preferred that the snap-on cap 110engage the shield 16 or the hub 12 with sufficient force to provide aseal with sufficient integrity to prevent ingress of contaminants intothe safety pen needle assembly 10.

With reference to FIGS. 23-24, an end cap 120 is shown for sealing thedistal opening 50 in the shield 16. The end cap 120 includes a base 122from which protrudes a tubular sidewall 124. Cooperating thread elements126, 128 are formed on the inside of the sidewall 124 and the shieldablumenal surface 46 so as to permit relative rotation between the endcap 120 and the shield 16. It is further preferred that the cooperatingthread elements 126, 128 have an opposing angular rotation to thecooperating thread elements 52, 54. It is also preferred that arotation-resistance arrangement 130 be provided which inhibits relativerotation between the end cap 120 and the shield 16. Therotation-resistance arrangement 130 may be formed in similar fashion tothe rotation-resistance arrangement 56, described above. Therotation-resistance arrangement 130 is surmountable to allow relativerotation between the end cap 120 and the shield 16 with an at leastthreshold amount of torque being applied therebetween. Preferably, thethreshold amount of torque is to be greater than the amount of torquerequired to mount the safety pen needle assembly 10 onto the injectorbody I and greater than the amount of torque required to surmount therotation-resistance arrangement 56. In this manner, torque may beapplied to the end cap 120 so as to permit full mounting of the safetypen needle assembly 10 onto the injector I and full proximaldisplacement of the shield 16 relative to the hub 12, prior toovercoming the rotation-resistance arrangement 130 to permit distaldisplacement of the end cap 120 relative to the shield 16 and ultimateseparation therefrom.

With reference to FIG. 16, as a further invention, the safety pen needleassembly 10 may be packaged for shipping and transportation without anyexternal casing or packaging. In particular, with reference to FIG. 16,the safety pen needle assembly 10 is provided with the shield 16 beingmovably mounted to the hub 12 so as to selectively cover the distal end30 of the needle 14. The shield 16 may be movably mounted to the hub 12in any manner including, but not limited to, the manner described above.An interface 132 is defined between the hub 12 and the shield 16.Preferably, the shield 16 is in a shielding state initially with thedistal end 30 being shielded by the shield 16. The interface 132 issufficiently sealed by portions of the hub 12 and/or the shield 16 so asto define a sterility barrier which prevents ingress of contaminantsthrough the interface 132.

The interface 132 may be sealed by various techniques, as will beappreciated by those skilled in the art. Preferably, the interface 132is sealed by a continuous barrier, such as provided by the points ofsecurement 58 described above. It is preferred that the points ofsecurement 58 extend continuously across the interface 132 withoutdisruption. As described above, the points of securement 58 may bedefined by adhesion, welding, fusion and/or integral portions of the hub12 and/or the shield 16. With the interface 132 being sealed, the hub 12and the shield 16 form a continuous body impervious to the passage ofcontaminants therethrough. Openings may be provided in the hub 12 and/orthe shield 16, such as the distal opening 50 in the shield 16, theproximal opening 23 in the hub 12 and/or the proximal opening 90 in thesecondary shield 76. At least one removable sterility barrier 134 ismounted directly to, and across, each of the openings so as to define asterility barrier therefor. Any peelable sterility barrier, e.g.film-based, may be utilized. Thus, as shown in FIG. 16, the distalopening 50 and the proximal opening 23 or 90 are each provided with atleast one of the sterility barriers 134. It is preferred that thesterility barriers 134 be removable, such as by peeling. It is possibleto have the sterility barriers 134 be rupturable to provide use of thesafety pen needle assembly 10.

For ease of removal, one or more straps 136 may be provided whichconnect two or more of the sterility barriers 134 so as to enableremoval of the sterility barriers 134 in groups of two or more. In thisfashion, it is possible to remove all of the sterility barriers 134 as asingle unit.

What is claimed is:
 1. A safety pen needle assembly comprising: a hubhaving a tubular side wall defining a lumen with an inner lumenalsurface and an outer ablumenal surface, a transverse wall extendingtransversely from said side wall to overlap at least a portion of saidlumen; a needle fixed to said transverse wall, said needle having adistal end, formed for insertion into a patient, and a proximal end;and, a shield having a shield side wall extending between proximal anddistal ends, said shield side wall being formed to at least partiallytelescope over said hub, said shield side wall defining a shield lumenwith an inner shield lumenal surface, wherein, said ablumenal surfaceand said shield lumenal surface being formed with cooperating threadelements to permit relative rotation between said hub and said shield,wherein, in an initial state, said cooperating thread elements being inthreaded engagement with said shield being positioned relative to saidhub with said distal end of said shield side wall being located distallyof said distal end of said needle, and, wherein, in said initial state,said shield and said hub being configured with a rotation-resistancearrangement which inhibits relative rotation between said hub and saidshield, said rotation-resistance arrangement being surmountable to allowrelative rotation between said hub and said shield with an at leastthreshold amount of torque being applied therebetween, said thresholdamount of torque being greater than required to mount said safety penneedle assembly onto an injector body.
 2. A safety pen needle assemblyas in claim 1, wherein a first thread element is disposed on saidlumenal surface of said hub formed for threaded engagement with aninjector body.
 3. A safety pen needle assembly as in claim 1, furthercomprising a secondary shield at least partially disposed in said lumenof said hub, said secondary shield having a secondary shield side wallextending between proximal and distal ends, said secondary shield sidewall defining a secondary shield lumen with an inner secondary shieldlumenal surface and an outer secondary shield ablumenal surface, saidsecondary shield side wall defining an opening to provide proximalaccess to said secondary shield lumen.
 4. A safety pen needle assemblyas in claim 3, wherein said lumenal surface and said secondary shieldablumenal surface being formed with secondary cooperating threadelements to permit relative rotation between said hub and said secondaryshield.
 5. A safety pen needle assembly as in claim 4, wherein, in saidinitial state, said secondary cooperating thread elements being inthreaded engagement with said secondary shield being positioned relativeto said hub with said proximal end of said secondary shield side wallbeing located distally of said proximal end of said needle.
 6. A safetypen needle assembly as in claim 4, wherein, in said initial state, saidsecondary cooperating thread elements being in threaded engagement withsaid secondary shield being positioned relative to said hub with saidproximal end of said secondary shield side wall being located proximallyof said proximal end of said needle.
 7. A safety pen needle assembly asin claim 4, wherein a first thread element is disposed on said secondaryshield lumenal surface formed for threaded engagement with an injectorbody.
 8. A safety pen needle assembly as in claim 1 further comprisinglocking means for locking said shield relative to said hub with saiddistal end of said shield side wall being located distally of saiddistal end of said needle.
 9. A safety pen needle assembly as in claim8, wherein, in said initial state, said shield is located proximally ofsaid locking state.